Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
Фаза 3
Завершено
NCT04248829
| Заболевание | Non-Small Cell Lung Cancer |
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| Фаза | Фаза 3 |
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| Спонсор | Yuhan Corporation |
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| Статус | Завершено |
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| Участники | 393 участн. |
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| Вмешательство | Lazertinib 240 mg/160 mg, Gefitinib 250 mg, Lazertinib-matching placebo 240 mg/160 mg, Gefitinib-matching placebo 250 mg |
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| Дата начала | 13.02.2020 |
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| Дата завершения | 29.07.2022 |
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| Публикация результатов | 22.03.2024 |
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Кратко
This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations
Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. · Months
| Lazertinib 240 mg | 20.6 Months |
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| Gefitnib 250 mg | 9.7 Months |
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